Device Recall Spacelabs Healthcare Xhibit Telemetry Receiver, Model 96280 의 리콜

Recall

73634

Class 2

Z-1502-2016

2016-03-28

Terminated

United States

2016-12-19

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144640

Reports of an abnormally high frequency of squelch events on xhibit telemetry receivers (xtr), which is indicative of the loss of the telemetry data signal. in some cases, the xhibit central monitor was also reported to display an xhibit offline error message for all patients being monitored.

On March 28, 2016, a customer letter will be sent via priority service, return receipt requested, to all U.S. customers. On April 4, 2016, a customer letter (translated as necessary) will be emailed to all international subsidiaries and distributors of record. Spacelabs recommends that you brief your staff regarding the failure modes listed above. If you continue to use affected Telemetry Receiver(s), please note: **When there is a loss of signal, a signal loss alarm is generated and a triangular-shaped squelch waveform is displayed for any channel exhibiting signal loss. If unacknowledged, this alarm will escalate to medium priority after five minutes. After an additional five minutes, this alarm will escalate to high priority. This failure is usually transient. **When the XTR goes offline, all telemetry waveform(s) associated with the XTR will disappear from the Central Station and an offline message will appear in each telemetry waveform zone. This failure is not recoverable. Please circulate this notification to all persons affected by the information it contains and add a copy to the appropriate monitor user manual until such time as corrections have been implemented by Spacelabs. Spacelabs will contact you to schedule a convenient time for Spacelabs to update your Xhibit Telemetry Receivers at no cost. If you have any questions about this corrective action, please contact Spacelabs at 1-800-522-7025 and select 2 for Technical Support.